SynerFuse has announced the first implantation in the company’s proof-of-concept study evaluating the safety and tolerability of simultaneously implanting spinal fusion hardware and a dorsal root ganglion (DRG) neurostimulator in patients suffering from chronic lower back pain (CLBP).
The first patient was implanted by Michael Park and Rohan Lall at M Health Fairview University of Minnesota Medical Center in Minneapolis, USA.
According to a company press release, the SynerFuse proof-of-concept study involves combining spinal fusion with the implant of a neurostimulator to stimulate the DRG—a key nerve structure along the spine that can be targeted with neuromodulation to treat chronic neuropathic pain.
The study will evaluate the safety and tolerability of this integrated therapy. Patients undergoing an initial spinal fusion, among other criteria, are eligible for the study, which is supporting the enrolment of up to 20 patients.
“The implantation of the first patient in our proof-of-concept study is an important milestone for SynerFuse,” said the company’s co-founder and CEO Justin Zenanko. “We are one step closer to demonstrating the viability of our non-narcotic solution for spinal fusion patients with chronic lower back pain.”
“Bringing this patient-focused therapy from concept to first implant is a true testament to collaboration within our company, and with our surgeon and staff partners at the University of Minnesota Medical School and M Health Fairview University of Minnesota Medical Center,” said SynerFuse co-founder and CSO Greg Molnar.